Sunita Kona
Belfast,Belfast
Summary
Design control specialist with over six years of experience in medical device and IVD product development within regulated environments. Expertise encompasses design controls, risk management, and regulatory compliance, including ISO 13485 and FDA 21 CFR Part 820. Demonstrated success in collaborating with cross-functional teams to propel product development from concept through design transfer.
Overview
2
2
Languages
1
1
Certification
21
21
years of professional experience
Work History
Design Control Specialist
NEOGENOMICS
10.2023 - Current
- Generated, reviewed, and updated Design Controls Documentation for medical devices and in-vitro diagnostics, ensuring compliance with regulatory requirements.
- Generated device requirements, including user requirements specifications and product requirements in Codebeamer X for software and medical devices.
- Support for the generation of technical documentation for the design and development of Medical Devices or In-vitro diagnostics.
- Support the generation, maintenance and updating of the Design History File and Design Master Record.
- Support to the planning, preparation and execution of Design Review.
- Support in the management of documents relating to the design history file in Codebeamer X.
- Support to the generation, review and update of SOPs in the field of Design Control of Device development.
- Assisted in the completion of design control milestones, including design inputs, outputs, verification/validation, and reviews, contributing to project timelines.
- Support of activities of Risk Assessment and preparation and archiving of Risk management file.
- Classified and archived technical documentation for design and development processes.
- Actively participate in work programs with a cross-functional team.
- Collaborated with product development team on analytical validation projects. Collaborated with project management team to design the development of a product to be compliant with business and customer needs.
Design Control Officer
ALMAC DIAGNOSTICS
01.2019 - 09.2023
- Managed design control documentation and supported internal strategies, policies, procedures, processes, and programmes to prevent violations of rules or regulations.
- Also design and deliver a risk management framework that maintains risk levels of a clinical trial assay within the IVD regulations.
- Created design control and risk management documents [design control plan, design inputs, design outputs, risk analysis etc.] necessary for the device design history and risk management file (DHF's).
- Facilitated completion of design control milestones, including design inputs, design outputs, and verification/validation activities, to align with project timelines.
- Identified, wrote, approved, and implemented design control procedures and assisted in training on new or revised procedures.
- Executed maintenance of internal document control system for design control and risk management documents, ensuring compliance and accessibility.
- Collaborated with product development development team (analytical validation) and project management team to design the development of a product to be compliant with business and customer needs.
- Actively assist/advice all departments within the product development team with the implementation of design control and risk management activities and ensure that design control procedures are continuously improved with the objective of assuring regulatory compliance and quality of manufactured IVD medical devices (Clinical trial assays).
- Assessed analytical validation protocols, data and reports to verify their accuracy and compliance with design and risk management requirements (ISO 13485 and 14971) and internal processes.
- Conducted thorough product documentation reviews (product proposals, product scope documents etc.).
- Monitor design control and risk management process applied to IVD device design and development.
- Participate in internal product teams implementing design control activities and ensure that these are being carried out in accordance with internal policies and procedures.
- Supported product team in design review and design change activities, ensuring timely follow-up on action items for effective project progression.
- Participated in internal audits of products audits of design controlled products.
Quality Assurance Executive
HCL TECHNOLOGIES
06.2013 - 12.2014
- Hands-on experience in performing quality check as a part of GAP analysis for different DHFs (Design history files) for the Product lines CMF, Spine, and Trauma by ensuring compliance to regulations and corporate templates and remediated the documents for FDA submission.
- Executed remediation activities by thoroughly evaluating design documentation for Design Input/output and Design Verification & Validation to ensure compliance readiness.
- Experience in reviewing Production Risk management documents for different orthopedic products as a part of Tech file remediation.
- Acquired expertise in ISO 13485, ISO 14971, and FDA regulations - 21 CFR Part 11 to enhance regulatory compliance efforts.
- Acquired knowledge of drug safety reporting procedures, including various reporting forms and Pharmacovigilance guidelines to ensure compliance.
- Capturing, recording and reporting of Adverse Events and Serious Adverse Events in accordance to the timelines.
- Facilitated discussions with customers regarding risks, hazards, and effects to ensure understanding and safety.
- Creation and updating of Functional and Design requirement matrix- Identification of clinical and regulatory need of the product and translation of the need to appropriate design specifications.
- Also suggested appropriate verification and validation method.
- Led team of four bioengineers to ensure alignment with client project requirements and deliverables.
- Monitor and improve quality of deliverables with CAR process performing additional role as a DPA (additional responsibility taken).
Safety Reviewer (Pharmacovigilance)
ACCENTURE SERVICES
Chennai
05.2007 - 04.2008
- Encodes verbatim terms using MedDRA for patient history, product indication, death information screen, and event term information.
- Maintained quality standards set by the client and Accenture.
- Read and transcribed large volumes of highly structured data into fields according to business rules, maintaining high quality standards.
- Entered case information into designated fields, ensuring comprehensive data capture.
- Conducted accurate data entry operations in Chennai, India, supporting efficient safety review processes.
- Plan and organize work so that SLAs are realised.
- Requires minimal supervision to manage daily activities and is able to meet published deadlines for activities.
- Selects appropriate narrative summary template (i.e.: spontaneous, literature, clinical trial).
- Enters labeling for all suspect products.
- Enters Reporter causality if indicated for spontaneous or literature files but is not required if it is not indicated.
- After completion of all the safety review fields attaches all necessary letters and/or queries in accordance with Data Entry Conventions.
Project Assistant (Clinical project coordinator)
ASIAN CLINICAL TRIALS
Hyderabad
10.2005 - 04.2007
- Ensured study-related documents were current at site and in-house, facilitating smooth project execution.
- Tracked and maintained study-related documents to ensure compliance and accessibility.
- Review the Trial Master File in a timely manner to ensure that up-to-date study documents are placed in them.
- Prepared documents for submission to the Ethics Committee.
- Prepared and monitored study-related information in logs for accurate reporting and reference.
- Prepared the agenda and minutes for project team meetings and client teleconferences.
- Participated in project team meetings to discuss progress and updates.
- Hyderabad, India
Education
Master - Microbiology
Andhra University
India01-2005
Bachelors - Microbiology, Biochemistry and Medical lab technology
Andhra University
Visakhapatnam01-2003
Skills
Design history file ownership
- Regulatory strategy
- Risk assessment
- Quality management
- Cross-functional leadership in medical devices
- Design transfer
- Product development
- Device combination products
- Usability engineering
- Project leadership
- Change management
- FDA inspections and operational excellence
- Cross-functional collaboration
- Product lifecycle management
Custom
2014-12-01, Present
Languages
English
Proficient
C2
Hindi
Proficient
C2
Certification
- [Type] Licence
Accomplishments
a { text-decoration: none; color: #464feb; } tr th, tr td { border: 1px solid #e6e6e6; } tr th { background-color: #f5f5f5; }
- 6+ years supporting Design Control, Risk Management, and DHF management activities for medical devices and IVD products.
- Successfully maintained and remediated DHFs, DMRs, and Risk Management Files to support regulatory compliance and inspection readiness.
- Coordinated cross-functional teams to achieve design control milestones, design reviews, verification, validation, and change management activities.
- Led DHF remediation projects for orthopedic medical devices, ensuring compliance with FDA and quality system requirements.
- Supported implementation of design control processes aligned with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and GMP expectations.
- Developed and maintained device requirements, traceability matrices, and risk management documentation throughout the product lifecycle.
- Contributed to continuous improvement initiatives that enhanced documentation quality, compliance, and operational efficiency
Timeline
Design Control Specialist
NEOGENOMICS
10.2023 - Current
Design Control Officer
ALMAC DIAGNOSTICS
01.2019 - 09.2023
Quality Assurance Executive
HCL TECHNOLOGIES
06.2013 - 12.2014
Safety Reviewer (Pharmacovigilance)
ACCENTURE SERVICES
05.2007 - 04.2008
Project Assistant (Clinical project coordinator)
ASIAN CLINICAL TRIALS
10.2005 - 04.2007
Master - Microbiology
Andhra University
Bachelors - Microbiology, Biochemistry and Medical lab technology
Andhra University